Biotech Values

[DewDiligence]

GNFT.PA claims advance in non-invasive NASH diagnostic:

https://globenewswire.com/news-release/2017/06/23/1028336/0/en/GENFIT-Reaches-a-Critical-Milestone-towards-the-Development-of-a-Non-Invasive-In-Vitro-Diagnostic-IVD-Test-for-NASH.html

Using a pretreatment dataset of the Phase 3 RESOLVE-IT study, after the screening of the first 500 patients, new results confirm the diagnostic potential of circulating microRNAs and the relevance of GENFIT's signature to identify patients with active NASH (NAS>or=4) and significant fibrosis (F>or=2), i.e. patients who should be treated:

• A new Next Generation Sequencing (NGS) experiment validates the diagnostic value of 13 circulating microRNAs, previously identified in GOLDEN-505 cohort and in a cohort of obese patients (Professor Sven Francque, LB 535, EASL 2017), in the Phase 3 RESOLVE-IT serum samples.

• A bioinformatics analysis confirms that a previously described signature combining miR-34a, alpha-2 macroglobulin, HbA1c and YKL-40 (Professor Stephan A. Harrison, LB 534, EASL 2017) has a significantly better diagnostic performance than other main scores described in the current literature, when tested in both GOLDEN-Diag and RESOLVE-IT cohorts…

The question, of course, is whether this works prospectively.